Pramatis

Leaflet accompanying the packaging: patient information

Pramatis, 5 mg, coated tablets

Pramatis, 10 mg, coated tablets

Pramatis, 20 mg, coated tablets

Escitalopram

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Pramatis and what is it used for
• 2. Important information before taking Pramatis
• 3. How to take Pramatis
• 4. Possible side effects
• 5. How to store Pramatis
• 6. Contents of the packaging and other information

1. What is Pramatis and what is it used for

Pramatis contains the active substance escitalopram. Pramatis belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs). These medicines work on the serotonin system in the brain, increasing serotonin levels. Disruptions in the serotonin system are thought to be a significant factor in the development of depression and related diseases. Pramatis is used to treat depression(episodes of major depression) and anxiety disorders(such as anxiety disorder with panic attacks, with or without agoraphobia, social phobia, generalized anxiety disorder, and obsessive-compulsive disorder). It may take several weeks before the patient feels better. Therefore, Pramatis should be taken continuously, even if the patient does not notice an improvement in their well-being at first. If there is no improvement or if the condition worsens, the doctor should be consulted.

2. Important information before taking Pramatis

When not to take Pramatis

• if the patient is allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6);
• if the patient is taking other medicines from the group of so-called monoamine oxidase inhibitors (MAOIs), including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic);
• if the patient has congenital heart rhythm disorders or has had such disorders in the past (detected in an electrocardiogram);
• if the patient is taking medicines that regulate heart rhythm or medicines that may affect heart rhythm (see below "Pramatis and other medicines").

Warnings and precautions

Before starting treatment with Pramatis, the patient should discuss it with their doctor or pharmacist. The patient should inform their doctor about any disorders or diseases they have, so that the doctor can take them into account. In particular, the patient should mention if they have epilepsy. Treatment with Pramatis should be discontinued if seizures occur for the first time or if the frequency of seizure attacks increases (see also section 4 "Possible side effects"); if the patient has liver or kidney problems. The doctor may need to adjust the dose of Pramatis; if the patient has diabetes. Taking Pramatis may change blood sugar levels, and it may be necessary to adjust the dosage of insulin and/or oral antidiabetic medicines; if the patient has low sodium levelsin the blood; if the patient has a tendency to bleedor bruise or if the patient is pregnant (see "Pregnancy"); if the patient is being treated with electroconvulsive therapy; if the patient has ischemic heart disease; if the patient has or has had heart function disorders or has recently had a heart attack; if the patient has slow resting heart rate and/or may have low levels of salts (e.g., due to prolonged, severe diarrhea, vomiting, or use of diuretics); if the patient experiences rapid or irregular heartbeat, fainting, or dizziness when standing up (which may indicate heart function disorders); if the patient has or has had eye disorders, such as a certain type of glaucoma (increased pressure in the eye).

Caution

In some patients with bipolar affective disorder(formerly called manic-depressive disorder), a manic phase may begin. This is characterized by the occurrence of unusual and rapidly changing ideas, unjustified joy, and excessive physical activity. If these symptoms occur, the patient should consult their doctor. In the first few weeks of treatment, symptoms such as restlessness, especially motor restlessness or difficulty sitting or standing stillmay also occur. The patient should immediately inform their doctor about the occurrence of these symptoms. Medicines like Pramatis (so-called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after discontinuation of treatment.

Thoughts of suicide and worsening of depression or anxiety disorder

Patients with depression and/or anxiety disorder may sometimes have thoughts of harming themselves or committing suicide. These thoughts may worsen at the beginning of treatment with antidepressant medicines, as it may take some time, usually about 2 weeks, or sometimes longer, for them to start working. This may be more likely to happen to the following patients:

• those who have had suicidal thoughts or self-harm thoughts in the past;
• young adults. Clinical trials have shown an increased risk of suicidal behavior in adults under 25 years of age with mental disorders treated with antidepressant medicines. If such thoughts of self-harm or suicide occur, the patient should contact their doctor or go directly to the hospital.

Sometimes it may be helpful to inform a relative or friendabout the depression or anxiety disorder and ask them to read this leaflet. The patient can also ask this person to pay attention if they notice a worsening of depression or anxiety or a change in the patient's behavior.

Children and adolescents

Pramatis should not be used in children and adolescents under 18 years of age. It should also be emphasized that during treatment with medicines from this group, patients under 18 years of age are at increased risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, rebellious behavior, and manifestations of anger). Nevertheless, the doctor may prescribe Pramatis to patients under 18 years of age if they consider it to be in the patient's best interest. If the doctor prescribes Pramatis to a patient under 18 years of age and this raises any doubts, the patient should consult their doctor. If the above-mentioned symptoms develop or worsen in patients under 18 years of age taking Pramatis, the patient should inform their doctor. Additionally, the long-term safety of using Pramatis in this age group has not been established in terms of growth, maturation, and cognitive and behavioral development.

Pramatis and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The patient should inform their doctor about taking the following medicines: non-selective monoamine oxidase inhibitors (MAOIs)containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active substances. If the patient is taking any of these medicines, they must wait 14 days before starting treatment with Pramatis. After stopping treatment with Pramatis, the patient must wait 7 days before starting to take any of these medicines; reversible, selective MAO-A inhibitorscontaining moclobemide (also used to treat depression); irreversible MAO-B inhibitorscontaining selegiline (used to treat Parkinson's disease). These medicines increase the risk of side effects; the antibiotic linezolid; lithium(a medicine used to treat manic-depressive disorder) and tryptophan; imipramine and desipramine(both used to treat depression); sumatriptan and similar medicines(used to treat migraines), tramadol(used to treat severe pain). These medicines increase the risk of side effects; buprenorphine(used to treat severe pain), as the risk of serotonin syndrome, a potentially life-threatening condition, increases; cimetidine, lansoprazole, and omeprazole(medicines used to treat stomach ulcers), fluconazole(a medicine used to treat fungal infections), fluvoxamine(an antidepressant), and ticlopidine(used to reduce the risk of stroke). These medicines may increase the levels of Pramatis in the blood; St. John's Wort (Hypericum perforatum)- a herbal medicine used to treat depression; acetylsalicylic acid and non-steroidal anti-inflammatory drugs (NSAIDs)(medicines used to reduce pain or thin the blood, so-called anticoagulants). These medicines may increase the risk of bleeding; warfarin, dipyridamole, phenprocoumon(medicines used to thin the blood, so-called anticoagulants). The doctor will probably check the patient's blood clotting time at the start of treatment and when stopping Pramatis to ensure that the anticoagulant dose is still correct; mefloquine(a medicine used to treat malaria), bupropion(used to treat depression), and tramadol(used to treat severe pain) due to the possible risk of lowering the seizure threshold; antipsychotic medicines(used to treat schizophrenia, psychosis) and antidepressant medicines (tricyclic antidepressants and SSRIs) due to the possible risk of lowering the seizure threshold; flecainide, propafenone, metoprolol(medicines used to treat cardiovascular diseases), clomipramine and nortriptyline(antidepressants), and risperidone, thioridazine, and haloperidol(antipsychotic medicines). The dose of Pramatis may need to be adjusted; medicines that lower blood potassium or magnesium levels, as this increases the risk of life-threatening heart rhythm disorders. Pramatis should not be taken if the patient is taking medicines that regulate heart rhythm or medicines that may affect heart rhythm, such as antiarrhythmic medicines of class IA and III, antipsychotic medicines (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibacterial medicines (i.e., sparfloxacin, moxifloxacin, intravenously administered erythromycin, pentamidine), antimalarial medicines (especially halofantrine), and certain antihistamines (astemizole, hydroxyzine, mizolastine). If in doubt about whether the patient is taking any of these medicines, they should consult their doctor.

Pramatis with food, drink, and alcohol

Pramatis can be taken with or without food (see section 3 "How to take Pramatis"). As with many medicines, it is not recommended to drink alcohol while taking Pramatis, although interactions between Pramatis and alcohol are unlikely to occur.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine. Pramatis should not be taken during pregnancy or breastfeeding without first discussing the risks and benefits of treatment with the doctor. If the patient takes Pramatis in the last three months of pregnancy, they should be aware that the following symptoms may occur in the newborn: breathing difficulties, blue discoloration of the skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or weakness, intense reflexes, trembling, nervousness, irritability, lethargy, persistent crying, and sleep disturbances. If the child experiences any of these symptoms, the patient should immediately contact their doctor. The patient should ensure that their midwife and/or doctor are aware that they are taking Pramatis. Medicines like Pramatis, taken during pregnancy (especially in the last three months), may increase the risk of a serious condition in the child, called persistent pulmonary hypertension in newborns, which causes rapid breathing and blue discoloration of the skin. These symptoms usually occur within the first 24 hours after birth. In such cases, the patient should immediately contact their midwife and/or doctor. If Pramatis is taken during pregnancy, the patient should never stop taking it abruptly. Taking Pramatis at the end of pregnancy may increase the risk of severe postpartum hemorrhage, which occurs shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient is taking Pramatis, they should inform their doctor or midwife so that they can provide appropriate advice. Escitalopram is likely to pass into breast milk. In animal studies, it has been shown that citalopram (a medicine similar to escitalopram) reduces sperm quality. This may theoretically affect fertility, although no effect on fertility has been observed in humans so far.

Driving and using machines

The patient should not drive or operate machinery until they know how Pramatis affects them.

Pramatis contains lactose and sodium

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine. This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means it is essentially "sodium-free".

3. How to take Pramatis

This medicine should always be taken exactly as prescribed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.

Adults

Depression The recommended dose is 10 mg taken once daily. The doctor may increase the dose to a maximum of 20 mg daily. Anxiety disorder with panic attacks The initial dose is 5 mg taken once daily for the first week of treatment, before increasing the dose to 10 mg daily. The doctor may then increase the dose to a maximum of 20 mg daily. Social phobia The recommended dose is 10 mg taken once daily. The doctor may reduce the dose to 5 mg daily or increase it to a maximum of 20 mg daily, depending on the patient's response to treatment. Generalized anxiety disorder The recommended initial dose is 10 mg taken once daily. The doctor may increase the dose to a maximum of 20 mg daily. Obsessive-compulsive disorder The recommended initial dose is 10 mg taken once daily. The doctor may increase the dose to a maximum of 20 mg daily.

Elderly patients (over 65 years of age)

The recommended initial dose of Pramatis is 5 mg taken once daily. The doctor may increase the dose to 10 mg daily.

Use in children and adolescents (under 18 years of age)

Pramatis should not be used in children and adolescents. For more information, see section 2 "Warnings and precautions".

Renal impairment

Caution should be exercised in patients with severe renal impairment. The medicine should be taken as prescribed by the doctor.

Hepatic impairment

Patients with hepatic impairment should not exceed a dose of 10 mg daily. The medicine should be taken as prescribed by the doctor.

Poor metabolizers of medicines involving the CYP2C19 isoenzyme

Patients with this known genotype should not exceed a dose of 10 mg daily. The medicine should be taken as prescribed by the doctor.

Method of administration

The medicine can be taken with or without food. The tablets should be swallowed with water. Only Pramatis, 10 mg: if necessary, the tablets can be divided into two equal doses. Only Pramatis, 20 mg: if necessary, the tablets can be divided into four equal doses.

Duration of treatment

It may take several weeks before the patient feels better. Pramatis should be taken continuously, even if it takes some time to notice an improvement in well-being. The patient should not change the dose of the medicine without consulting their doctor. The medicine should be taken for as long as prescribed by the doctor. Stopping treatment too early may cause the symptoms to return. It is recommended to take the medicine for at least 6 months after feeling better.

Taking a higher dose of Pramatis than recommended

If the patient takes a higher dose of Pramatis than recommended, they should immediately contact their doctor or the emergency department of the nearest hospital, even if they do not experience any symptoms or feel unwell. Symptoms that may occur include: dizziness, trembling, agitation, seizures, coma, nausea, vomiting, heart rhythm disorders, low blood pressure, and electrolyte imbalance. The patient should take the packaging of Pramatis with them to the doctor or hospital.

Missing a dose of Pramatis

The patient should not take a double dose to make up for a missed tablet. If the patient forgets to take a dose and remembers before going to bed, they should take the missed tablet. The next day, they should take the medicine as usual. If the patient remembers about the missed dose at night, they should skip it and take the next tablet at the usual time.

Stopping treatment with Pramatis

The patient should not stop taking Pramatis without consulting their doctor. When stopping treatment, the dose of Pramatis is usually gradually reduced over several weeks. After stopping Pramatis, especially abruptly, the patient may experience withdrawal symptoms. This is a common phenomenon after stopping treatment with escitalopram, especially if Pramatis has been taken for a long time and in high doses or if the dose has been reduced too quickly. In most cases, these symptoms are mild and disappear within 2 weeks. However, in some patients, the symptoms may be severe or may last for a long time (2 to 3 months or longer). If the patient experiences severe withdrawal symptoms after stopping Pramatis, they should contact their doctor. The doctor may recommend restarting treatment with Pramatis and then gradually reducing the dose. Withdrawal symptoms include:dizziness (unsteadiness or loss of balance), tingling sensation, feeling of burning, and (less commonly) electric shock sensation, sleep disturbances (vivid dreams, nightmares, or difficulty falling asleep), anxiety, headaches, nausea, sweating (including night sweats), feeling of restlessness or agitation, trembling, feeling of confusion or disorientation, mood swings or irritability, diarrhea (loose stools), vision disturbances, feeling of palpitations or pounding heart (palpitations). If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Pramatis can cause side effects, although not everybody gets them. Side effects usually disappear after a few weeks of treatment. It should be remembered that many of these side effects may also be symptoms of the underlying disease, so they will decrease as the patient's condition improves.

If the patient experiences any of the following side effects, they should contact their doctor or go directly to the hospital.

Uncommon (may affect up to 1 in 100 people) unusual bleeding, including gastrointestinal bleeding. Rare (may affect up to 1 in 1,000 people) swelling of the skin, tongue, lips, throat, or face, hives, or difficulty breathing or swallowing (severe allergic reaction); high fever, agitation, confusion, trembling, and sudden muscle contractions (may be symptoms of a rare condition called serotonin syndrome), (see section 2). Frequency not known (cannot be estimated from the available data) difficulty urinating; seizures, see also section 2 "Warnings and precautions"; yellowing of the skin and whites of the eyes (symptoms of liver dysfunction or hepatitis); rapid or irregular heartbeat, fainting - may be symptoms of life-threatening heart rhythm disorders of the type torsades de pointes; thoughts of self-harm or suicide (see also "Warnings and precautions"); sudden swelling of the skin or mucous membranes (angioedema).

The following side effects have also been reported:

Very common (may affect more than 1 in 10 people) nausea; headache. Common (may affect up to 1 in 10 people) blocked nose or runny nose (sinusitis); decreased or increased appetite; anxiety, restlessness, unusual dreams, difficulty falling asleep, drowsiness, dizziness, yawning, trembling, tingling sensation; diarrhea, constipation, vomiting, dry mouth; increased sweating; muscle or joint pain; sexual dysfunction (delayed ejaculation, erectile dysfunction, decreased libido, difficulty achieving orgasm in women); feeling of fatigue, fever; weight gain. Uncommon (may affect up to 1 in 100 people) hives, rash, itching; teeth grinding, agitation, nervousness, panic attacks, confusion; taste disturbances, sleep disturbances, fainting; dilated pupils, vision disturbances, ringing in the ears (tinnitus); hair loss; heavy menstrual bleeding; irregular menstrual periods; weight loss; rapid heartbeat; swelling of the hands or feet; nosebleeds. Rare (may affect up to 1 in 1,000 people) aggression, depersonalization, hallucinations; slow heartbeat; Frequency not known (cannot be estimated from the available data) low sodium levels in the blood (symptoms are nausea and malaise with muscle weakness or confusion); dizziness when standing up, caused by low blood pressure (orthostatic hypotension); abnormal liver function test results (elevated liver enzyme activity in the blood); movement disorders (involuntary muscle movements); painful erection of the penis (priapism); symptoms of abnormal bleeding, e.g., in the skin and mucous membranes (ecchymoses); increased secretion of antidiuretic hormone (ADH), leading to water retention in the body, blood dilution, and low sodium levels; milk secretion in men and in women who are not breastfeeding; mania; change in heart rhythm (so-called "QT interval prolongation", detected in an electrocardiogram); severe postpartum hemorrhage, see additional information in the "Pregnancy" subsection of section 2. Additionally, it is known that several side effects are associated with the use of medicines with a similar action to escitalopram (the active substance of Pramatis). These include: motor restlessness (akathisia); loss of appetite; increased risk of fractures.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301/fax: +48 22 49 21 309/website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of this medicine.

5. How to store Pramatis

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the label or carton after EXP. The expiry date refers to the last day of the month stated. There are no special storage precautions. HDPE bottles After the first opening, the tablets can be stored in the opened HDPE bottle for a maximum of 6 months. Do not store the opened bottle in temperatures above 25°C. After the 6-month period, the patient should not take the tablets that remain in the bottle but should dispose of them. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Pramatis contains

• The active substance is escitalopram. Each coated tablet contains 5 mg, 10 mg, or 20 mg of the active substance - escitalopram (as escitalopram oxalate).
• The medicine also contains: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose, hypromellose, magnesium stearate, silicon dioxide. Tablet coating: hypromellose, macrogol 6000, titanium dioxide (E 171), talc.

What Pramatis looks like and contents of the pack

Pramatis, 5 mg: white, round, coated tablets with a diameter of 5.7-6.3 mm. Pramatis, 10 mg: white, oval, coated tablets with a length of 7.7-8.3 mm and a width of 5.2-5.8 mm, with a score line on one side to facilitate breaking. Pramatis, 20 mg: white, round, coated tablets with a diameter of 9.2-9.8 mm, with intersecting score lines on both sides to facilitate breaking. The medicine is available in the following packs: Blister packs of OPA/Aluminum/PVC/Aluminum in a cardboard box Pramatis, 5 mg and Pramatis, 20 mg: 28 or 30 tablets Pramatis, 10 mg: 28, 30, or 56 tablets HDPE bottles with a PP cap containing a desiccant in a cardboard box 28 or 30 tablets

Marketing authorization holder and manufacturer

Marketing authorization holder Sandoz GmbH Biochemiestrasse 10 6250 Kundl, Austria Manufacturer Salutas Pharma GmbH Otto-von-Guericke-Allee 1 39179 Barleben, Germany Lek S.A. ul. Domaniewska 50 C 02-672 Warsaw, Poland Lek Pharmaceuticals d.d. Verovškova 57 1526 Ljubljana, Slovenia Lek S.A. ul. Podlipie 16 95-010 Stryków, Poland

For more information about this medicine and its names in other European Economic Area countries, please contact:

Sandoz Polska Sp. z o.o. ul. Domaniewska 50 C 02-672 Warsaw tel. 22 209 70 00 Date of last revision of the leaflet: 10/2024 Sandoz logo